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Summary of Contents for Primedic HeartSave PAD
- Page 1 HeartSave PAD Operating instructions MGA 22289/ GB / C...
- Page 2 Masthead Publisher METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Germany Proprietary note METRAX GmbH reserves all rights to these operating instructions. Without approval from METRAX GmbH, these operating instructions may not be duplicated or made accessible to third parties. The same applies to individual parts or excerpts of these operating instructions. Non-compliance with this gives rise to a right to claim damages and can have consequences under criminal law (refer to DIN 34).
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Page 3: Table Of Contents
Automatic, periodic self-tests ..................27 Operating the device and sequence of reanimation Switching the PRIMEDIC™ HeartSave PAD on / off ..........28 7.1.1 Switching the PRIMEDIC™ HeartSave PAD on ..........28 7.1.2 ... - Page 4 Index of diagrams Use of devices on ships 17.1 Use of PRIMEDIC™ HeartSave devices with PRIMEDIC™ Battery on merchant navy ships: 55 17.2 Use of PRIMEDIC™ HeartSave devices with PRIMEDIC™ AkuPak on merchant navy ships: 55 ...
- Page 5 Introduction Operating instructions HeartSave PAD 22289 / GB / C...
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Page 6: Introduction
1 Introduction 1.1 Foreword Dear User, You are faced with the task of using the PRIMEDIC™ HeartSave PAD in a medical emergency on human beings. To ensure that you can react quickly and correctly in this special situation and can... -
Page 7: Disclaimers
Autonomous intervention, repairs or constructional changes to the device. Autonomous overrunning of the performance limits. Lack of monitoring parts that are subject to wear and tear. Treatment of patients without prior indication. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 8: Symbols Used In These Operating Instructions
Numbers in brackets refer to items in diagrams. < ... > Texts set in angle brackets denote acoustic information / instructions of the device which are shown simultaneously on the monitor, depending on the device model. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 9: Pictograms On The Device
GERMANISCHER LLOYD type approval certificate no. 75 449-09 HH 1.7 Pictograms on SavePads Not to be reused Expiry date Batch ID Only for adults Order number Storage temperature information in Celsius and Fahrenheit Operating instructions HeartSave PAD 22289 / GB / C... -
Page 10: Intended Use
The PRIMEDIC™ HeartSave PAD devices may only be used as described and Note under the conditions detailed in these operating instructions. The operator of the HeartSave PAD has to make sure that the HeartSave PAD is only used by authorised specialist personnel. WARNING Any use above or beyond this is not considered as intended use and can lead to personal injury or damage to property. -
Page 11: Indication/Contraindication For Defibrillation
Intended use 2.1 Indication/Contraindication for Defibrillation 2.1.1 Indications The PRIMEDIC™ HeartSave PAD may only be used if the patient: is unconscious and not breathing 2.1.2 Contraindications The PRIMEDIC™ HeartSave PAD may not be used if the patient: ... -
Page 12: Safety Information
3.1 General information Both in conjunction with its accessories and the optional accessories, and also individually, the PRIMEDIC™ HeartSave PAD fulfils the currently applicable safety standards and complies with the provisions of the medical products regulations. The device and its accessories are safe when used as intended and taking into account the descriptions and information detailed in these operating instructions. - Page 13 Apart from that, the device can be damaged or destroyed through improper use. Note Observe the information and rules in the appendix on using the PRIMEDIC™ HeartSave PAD. Applicable for Europe: The device complies with the Medical Device Directive (MDD).
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Page 14: General Safety Instructions
(such as gels, blood or salt solutions) and metallic objects around the patient (such as bed frame or traction devices) which present unintended paths for the defibrillation current. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 15: Safety Notes For Protection Of The Patient
Only connect the adhesive electrodes to the PRIMEDIC™ HeartSave PAD. Using the electrodes with other devices can cause the patient to be given dangerous leakage currents. Do not use the device in the immediate vicinity of other sensitive equipment (e.g. - Page 16 If the ECG analysis is being carried out in a vehicle, the vehicle has to stop and switch off the engine to guarantee a correct analysis. Stop any reanimation while the PRIMEDIC™ HeartSave PAD is analysing the ECG. Do not touch the patient during defibrillation. Avoid any contact between ...
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Page 17: Safety Notes For The Protection Of Third Parties
3.6 Safety notes for the protection of the device CAUTION Damage to property Repairs, changes, extensions and installations of the PRIMEDIC™ HeartSave PAD may only be carried out by personnel authorised and trained by METRAX The PRIMEDIC™ HeartSave PAD does not have any parts that can be repaired by the user. -
Page 18: Description Of Device
ECG rhythm. This method is the generally recognised therapy. The PRIMEDIC™ HeartSave product family has been designed to be safe and quick to use in an emergency. All functional units are operating elements subject to the following principles: ... -
Page 19: Description Of Device Details
(3) Strap to pull the cover off the device (with expiry date SavePads) (4) Status display Fig. 2: HeartSave PAD rear view (1) Receptacle opening for hook of the wall bracket (2) Specification plate Operating instructions HeartSave PAD 22289 / GB / C... - Page 20 Fig. 3: HeartSave PAD View from underneath (1) Release button for SaveCard (2) Slot for SaveCard (3) Release button (4) Contacts for power module Fig. 4: HeartSave PAD operating controls (1) On/Off button (2) Electrode symbol with LED (3) Membrane keyboard with patient symbol (4) "Do not touch patient"...
- Page 21 Fig. 5: Primedic utensils carrier with SavePads (1) Primedic SavePads (defibrillation electrodes) (2) Artificial respiration cloth and razor (3) Quick instructions, several languages (4) Rubber gloves, not sterilised (5) Primedic utensils carrier with expiry date SavePads Operating instructions HeartSave PAD 22289 / GB / C...
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Page 22: Status Display
< Battery low, please replace battery > If the device is being used, the corresponding audible warning will be Note repeated regularly in the selected language. The battery symbol in the status display is activated. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 23: Data Management
There you enter the following: format f: /U /FS:FAT /X /V: (where f: stands for the drive letter of the of the CF card reading device which you may have to adjust). Operating instructions HeartSave PAD 22289 / GB / C... -
Page 24: Description Of The Accessories
4.5 Description of the accessories The accessories need to be secured appropriately before being transported. 4.5.1 Primedic SavePads Fig. 6: Primedic SavePads (1) Plug of the defibrillation electrodes (Primedic SavePads) (2) Defibrillation electrodes with protective film 4.5.2 Optional accessories ... -
Page 25: Preparatory Measures Before (Initial) Start-Up
Endangering health can not be ruled out. Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note. Dispose of the packaging material in an environmentally-friendly manner. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 26: Inserting / Changing The Savecard
The device is ready for use both with an exhausted memory and also without a SaveCard. To read out the saved data, you can use the software PRIMEDIC™ ECG Viewer which is available as an optional accessory. -
Page 27: Inserting / Changing The Power Supply Unit (Battery)
Preparatory measures before (initial) start-up 5.3 Inserting / Changing the power supply unit (Battery) Before using the PRIMEDIC™ HeartSave PAD for the first time, the battery has to be inserted in the appropriate slot. The HeartSave PAD is always supplied with a battery. -
Page 28: Removing The Battery From The Device
Twist the power module slightly in the direction of the arrow (1st) and then pull it in the direction of the arrow (2nd) out of the device. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 29: Primedic™ Battery
If the device has to be sent away to technical services, remove the battery Note before sending it and put some adhesive insulation tape over its contacts. When sending the battery, observe the separate shipping regulations. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 30: Device Self-Test
6.1 Self-test after switching on the HeartSave PAD The self-test is triggered by switching on the PRIMEDIC™ HeartSave PAD or by inserting the battery in the device. The HeartSave PAD runs a device self-test to check all the important parameters and signal mechanisms. -
Page 31: Operating The Device And Sequence Of Reanimation
Standby is confirmed by a beep. It is important to ensure that the loudspeaker is working. 7.1.2 Switching the PRIMEDIC™ HeartSave PAD off The PRIMEDIC™ HeartSave PAD can be switched off in different ways: By pressing the on/off button for approx. 3 seconds. A warning beep will sound simultaneously. -
Page 32: Voice Output By The Device / Preliminary Examination Of The Patient
< Plug in electrode cable > 7.3 Undressing the patient If during your preliminary examination, you have ascertained that the patient Note may need defibrillation, undress the upper body to be able to position the electrodes. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 33: Determining The Position Of The Electrodes
In certain situations (e.g. after an acute myocardial infarction), it may be necessary to dry the skin in the respective positions. A dry surface is essential for the adhesive electrodes to stick on. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 34: Opening Savepads And Positioning Electrodes
Fig. 11: Removing the film from the electrodes (1) Protective film on electrodes (2) SavePads adhesive electrodes The PRIMEDIC™ HeartSave PAD will give spoken instructions for you to apply the defibrillation electrodes to the patient. < Apply electrodes to patients bare chest >... -
Page 35: Plugging In The Electrode Plugs
After the voice message asks you to < Plug in electrode cable >, insert the plug of the electrode cable into the jack on the HeartSave PAD as shown in the diagram above. Make sure that the locking pin locks into place. -
Page 36: Checking The Electrodes
Hair on patient has not been removed Air pockets between skin and defibrillation electrodes cause a bad contact. Dried out electrodes. Remedy the cause of the fault. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 37: Carrying Out The Ecg Analysis
15 seconds and is signalled by a continuous beep and the trigger button lighting up "green". If you do not defibrillate within this period, an internal safety discharge will follow and the ECG will be analysed again. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 38: Defibrillation Not Required
< No shock advised > < Cardiopulmonary resuscitation > < Give 30 chest compressions > < Give 2 rescue breaths > Once the CPR time has expired, the device returns to ECG analysis. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 39: Keep The Defibrillator Ready For Use
At the end of a reanimation, clean the device, replace the SavePads and check or if necessary exchange the power supply unit so that the PRIMEDIC™ HeartSave PAD is ready to use again for the next time as soon as possible. -
Page 40: Cleaning, Maintenance And Dispatch
Clean the device and all its accessories, such as the wall bracket, with commercially available household cleaners. Use a slightly damp, clean cloth. Use normal disinfectant to disinfect it (e.g. Gigasept FF, Bacillol or Spitacid). Operating instructions HeartSave PAD 22289 / GB / C... -
Page 41: Servicing
8.2 Servicing Independently of the use of the device, we recommend regular visual inspection / servicing of the PRIMEDIC™ HeartSave PAD and the accessories by the user / service technician at least once a year. Make sure that the housing, cable, SavePads and all the other accessories are undamaged. -
Page 42: Dispatching The Primedic™ Heartsave Pad
If you want to return the device for additional equipping or for a service, it is Note important that you remove the power module from the device first and include it with the device, but packaged separately. Where possible, use the original box. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 43: Disposal
Please contact your dealer or supplier if you want to dispose of electrical and electronic equipment. He will have further information on this for you. Information for disposal in countries outside the European Union This symbol is only applicable within the European Union. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 44: Technical Data
Input d.c. voltage: ± 0.5 V Bandwidth: 0.5 – 44 Hz (- 3 dB) SR = 101 samples/s Impedance measurement Defibrillation: 23 ... 200 Ohm (accuracy +/-20 %) 30 kHz Measurement frequency: Operating instructions HeartSave PAD 22289 / GB / C... - Page 45 Standards (for licensing in the EU the corresponding harmonised Standards applied European standards EN were used instead of the IEC standards): IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-2:2001 IEC 60601-2-4:2002 EN1789:2003 Subject to change without notice. Operating instructions HeartSave PAD 22289 / GB / C...
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Page 46: Warranty Conditions
In the case of a warranty claim, please return the device with proof of purchase (e.g. invoice) stating your name and address to your dealer or to METRAX. METRAX After-Sales Service is glad to be at your disposal, even after the warranty period has expired. Operating instructions HeartSave PAD 22289 / GB / C... -
Page 47: Depiction Of The Current Time Function
12 Depiction of the current time function Below you can see the graph shapes of the defibrillation impulse in manual mode depending on the load resistance. Stage 1 Stage 2 Stage 3 Operating instructions HeartSave PAD 22289 / GB / C... - Page 48 Depiction of the current time function Stage 1 Stage 2 Stage 3 Operating instructions HeartSave PAD 22289 / GB / C...
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Page 49: Rhythm Detection System
Optical and acoustic messages are emitted to show you that the device recommends giving a defibrillation shock. If a defibrillation shock is recommended, you decide whether and when the shock is to be given. Operating instructions HeartSave PAD 22289 / GB / C... - Page 50 Total number of ECGs in which dispensing an impulse by the device is not recommended Positive predictive value = Number of "correct shockable" algorithm decisions Total number of ECGs in which dispensing an impulse is recommended by the device VF Operating instructions HeartSave PAD 22289 / GB / C...
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Page 51: Guidelines And Manufacturer's Declaration - Electromagnetic Emissions
IEC 61000-3-2 residential purposes. Emission of voltage fluctuations / flickering according Compliant IEC 61000-3-3 Operating instructions HeartSave PAD 22289 / GB / C... - Page 52 The quality of the supply voltage should interference/bursts lines correspond to that of a typical commercial or according to ± 1 kV for input and hospital environment. output lines IEC 61000-4-4 Operating instructions HeartSave PAD 22289 / GB / C...
- Page 53 (50/60 should correspond to the typical values found Hz) according to in a commercial or hospital environment. IEC 61000-4-8 COMMENT is the a.c. supply voltage before applying the impulse test levels. Operating instructions HeartSave PAD 22289 / GB / C...
- Page 54 To determine the electromagnetic environment with regards to the stationary transmitters, a study of the location should be considered. If the field strength measured at the location at which the PRIMEDIC™ HeartSave is being used exceeds the conformance levels for HF listed above, then the PRIMEDIC™ HeartSave should be observed to prove that it is functioning as intended.
- Page 55 The PRIMEDIC HeartSave family is designed for use in an electromagnetic environment in which the HF interference is controlled. The customer or user of the PRIMEDIC HeartSave can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the PRIMEDIC HeartSave –...
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Page 56: Safety Checks
This applies in particular for readjustments, repairs and changes to the device. To always be able to keep the records up to date, you will find our STK test reports on the Internet at www.primedic.de in the area "Service." Operating instructions HeartSave PAD 22289 / GB / C... -
Page 57: Index Of Diagrams
Fig. 1: HeartSave PAD front view ..................... 16 Fig. 2: HeartSave PAD rear view ....................16 Fig. 3: HeartSave PAD View from underneath ................17 Fig. 4: HeartSave PAD operating controls ................17 Fig. 5: Primedic utensils carrier with SavePads ................18 Fig. -
Page 58: Use Of Devices On Ships
Lloyd,” 2003. As the “PRIMEDIC™ AkuPak 12VDC 1,2Ah NiCd” behaves as the “PRIMEDIC™ Battery” during supply of PRIMEDIC™ HeartSave (M250) devices, the experience of the all EMC tests results can be transferred to the combinations PRIMEDIC™ AkuPak / PRIMEDIC™ HeartSave (M250) devices. -
Page 59: Contact Details
Use of devices on ships Contact details METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Phone: +49 (0) 741/257-0 Email: sales@primedic.de Web: www.primedic.de Operating instructions HeartSave PAD 22289 / GB / C... - Page 60 Headquarter/Manufacturing: developing state-of-the-art devices friendly that they set new standards. METRAX GmbH for emergency medicine. Established With the brand PRIMEDIC™, Rheinwaldstr. 22 in 1973 in Rottweil, today Metrax is Metrax offers a reliable program for D-78628 Rottweil Germany...
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